Varenicline in smokers with severe or very severe COPD after 24 weeks of treatment. A descriptive analysis: VALUE study.

A large number of COPD patients are smokers. The particular characteristics of this group as well as their need to quit usually require psychological counselling and pharmacological treatment to achieve abstinence and, often, intensively. Little information is available about this issue.  The main objective of the study was to evaluate the effectiveness of varenicline after 24 weeks of treatment, with continuous abstinence between weeks 9 and 24.  This study was a post-authorization, open label, observational study of prospective follow-up. Patients included were smokers with severe or very severe COPD criteria who were treated with varenicline for 24 weeks, i.e. with a 12-week extension over the usual treatment.  The outcomes in the population of subjects completing 24 weeks of follow-up were at week 24: continuous abstinence 36.8%, 7 days point prevalence abstinence 65.7%, and continuous smoking 31.5%.The outcomes in the intention-to-treat population included at baseline were: continuous abstinence 17.7% of patients, 7 days point prevalence abstinence 31.6%, continuous smoking 15.1% and not valid/unknown 51.8%.  The mean CAT score at week 24 was 15 and reduction from the baseline was 3.77 (paired T test, p<0.01). The most common adverse events reported were nausea, vivid dreams, stomach ache, insomnia, headache and vomiting.  Patients included in VALUE were active smokers despite all of them had a severe COPD which suggests a very high degree of dependence. Although the study do not allow to infer the results to the global population of smokers with severe COPD, the outcomes have shown that, at 24 weeks follow up 36.8% of the patients were successful in quitting but from 79 patients enrolled initially only 17.7% quit.

The effect of pulmonary rehabilitation on cardiovascular risk, oxidative stress and systemic inflammation in patients with COPD.

PURPOSE: Chronic obstructive pulmonary disease (COPD) is a leading cause of death, and cardiovascular (CV) comorbidities play a role. Evidence of the pulmonary rehabilitation (PR) effect in reducing the CV risk (CVR) in COPD patients is limited. In this study, we aimed to determine the impact of an 8-week PR program (PRP) on the CVR of the overall population and to compare the impact on the exacerbator versus non-exacerbator patients. PATIENTS AND METHODS: This was a prospective study that included adults who had post-bronchodilator forced expiratory volume in 1 s (FEV1) to forced vital capacity (FVC) (FEV1/FVC) ratio <70 % and FEV1 <80 % predicted, had quit smoking for at least 1 year and had a history of tobacco consumption greater than 10 packs/year, and were clinically stable in the last 8 weeks. Pre- and post-PRP assessments included respiratory function evaluation, laboratory tests, and exercise capacity assessment (6-min walking test [6MWT]). CVR was assessed using different risk prediction models. RESULTS: A total of 50 patients (28 exacerbators and 22 non-exacerbators) completed the PRP (median age: 64.5 years, men: 72 %; arterial hypertension: 70 %, dyslipidemia: 30 %, diabetes: 20 %; CV disease (CVD): 24 %. After the PRP, exacerbator patients showed a significant decrease in the CVR calculated by the COPDCoRi model (p < 0.001); patients with ≥30-m increase on the 6MWT showed statistically significant lower levels of glucose (p = 0.004), HbA1c (p = 0.004) and BODE index score (p = 0.026) compared to patients with <30-m increase. CONCLUSIONS: PR reduced certain modifiable CVR factors and CVD risk, especially in exacerbator patients.

Effectiveness of a respiratory rehabilitation programme in patients with chronic obstructive pulmonary disease. / Efectividad de un programa de rehabilitación respiratoria en pacientes con enfermedad pulmonar obstructiva crónica.

OBJECTIVE: To evaluate the effectiveness of the multidisciplinary respiratory rehabilitation (RR) programme in patients with severe or very severe chronic obstructive pulmonary disease pre the RR programme, at the end of the programme and one year after the RR, measuring changes in ability to exercise (walking test), effort tolerance(forced expiratory volume (FEV1)) and health-related quality of life. METHOD: Quasi-experimental single group design. We included patients diagnosed with severe or very severe chronic obstructive pulmonary disease (stages III and IV of the GOLD classification) who entered the rehabilitation programme for the years 2011 and 2012. Demographic data, questionnaires on general health-related quality of life (SF-36) and specific to respiratory patients (St George's Respiratory Questionnaire), FEV1% and exercise capacity test (running test 6minutes) were collected. Data were collected before the RR programme, at the end of the RR programme and a year after completing the program. RESULTS: No significant differences in FEV1% values were observed. Regarding exercise capacity, an increase in distance walked in the walking test was noted, which changed significantly after training, 377±59.7 to 415±79 m after one year (P<.01). A statistically significant improvement in mean scores of HRQoL was observed, except for the emotional role dimension of the SF-36 questionnaire. CONCLUSION: A pulmonary rehabilitation programme for 8 weeks improved the exercise capacity, dyspnoea and quality of life of patients with severe and very severe chronic obstructive pulmonary disease.